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Browse Drug Recalls

6,220 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,220 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 6,220 FDA drug recalls.

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DateProductReasonClassFirm
Feb 29, 2024 FentaNYL citrate, 10 mcg in 0.9% Sodium Chloride 1 mL Vial (10 mcg/mL), 1.5 m... Lack of Assurance of Sterility: Firm did not perform process validation. Class II SSM Health Care St. Louis DBA SSM St. Clare Hea...
Feb 29, 2024 TRP Natural Eyes Pink Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ ... Lack of Assurance of Sterility Class II Optikem International, Inc.
Feb 29, 2024 TRP Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15mL), Manufacture... Lack of Assurance of Sterility Class II Optikem International, Inc.
Feb 29, 2024 TRP Eye Twitching Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), ... Lack of Assurance of Sterility Class II Optikem International, Inc.
Feb 29, 2024 TRP Natural Eyes Red Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (... Lack of Assurance of Sterility Class II Optikem International, Inc.
Feb 29, 2024 TRP Eye strain Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ (10 mL), Ma... Lack of Assurance of Sterility Class II Optikem International, Inc.
Feb 29, 2024 TRP Natural Eyes Aging Eye Relief, Sterile Eye Drops, Homeopathic, 0.33 FL OZ... Lack of Assurance of Sterility Class II Optikem International, Inc.
Feb 29, 2024 TRP Natural Eyes Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL ... Lack of Assurance of Sterility Class II Optikem International, Inc.
Feb 29, 2024 TRP Natural Eyes Floaters Relief, Sterile Eye Drops, 0.33 FL OZ (10 mL), Manu... Lack of Assurance of Sterility Class II Optikem International, Inc.
Feb 29, 2024 Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenou... Lack of Assurance of Sterility: Firm did not perform process validation. Class II SSM Health Care St. Louis DBA SSM St. Clare Hea...
Jan 30, 2024 Equate Stye Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%... Lack of Assurance of Sterility Class II Brassica Pharma Pvt Ltd
Jan 30, 2024 Lubricant PM Ointment (Mineral Oil 42.5% and White Petrolatum 57.3%), Package... Lack of Assurance of Sterility Class II Brassica Pharma Pvt Ltd
Jan 30, 2024 CVS Health Lubricant Eye Ointment (Mineral oil 31.9% Emollient, White petrol... Lack of Assurance of Sterility Class II Brassica Pharma Pvt Ltd
Jan 30, 2024 Equate Lubricant Eye Ointment (Mineral Oil 42.5%, White Petrolatum 57.3%), Pa... Lack of Assurance of Sterility Class II Brassica Pharma Pvt Ltd
Jan 10, 2024 Fosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for I... Lack of Sterility Assurance: Aseptic process simulation failure. Class II BE PHARMACEUTICALS AG
Dec 28, 2023 DELFLEX Peritoneal Dialysis Solution in Biofine container 1.5% Dextrose, pack... Lack of Sterility Assurance Class II Fresenius Medical Care Holdings, Inc.
Nov 22, 2023 ceFAZolin sodium in Sterile Water for injection, Injectable Solution, 1g/10mL... Lack of assurance of sterility. Class II Wells Pharma of Houston LLC
Nov 13, 2023 Lubricant Eye Drops (Propylene glycol 0.6%), packaged in 0.33 FL OZ (10 mL) e... Non-Sterility Class I Kilitch Healthcare India Limited
Nov 13, 2023 Leader brand Dry Eye Relief (Polyethylene glycol 400 0.4% and Propylene glyco... Non-Sterility Class I Kilitch Healthcare India Limited
Nov 13, 2023 Lubricant Gel Drops (Carboxymethylcellulose sodium 1.0%), packaged in 0.5 FL ... Non-Sterility Class I Kilitch Healthcare India Limited
Nov 13, 2023 Lubricant Gel Drops (Polyethylene glycol 400 0.4%, Propylene glycol 0.3%), pa... Non-Sterility Class I Kilitch Healthcare India Limited
Nov 13, 2023 Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL ... Non-Sterility Class I Kilitch Healthcare India Limited
Nov 13, 2023 Leader brand Dry Eye Relief (Carboxymethylcellulose Sodium 1%), packaged in 0... Non-Sterility Class I Kilitch Healthcare India Limited
Nov 13, 2023 Leader brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packag... Non-Sterility Class I Kilitch Healthcare India Limited
Nov 13, 2023 CVS Health brand, Lubricant Gel Drops (Carboxymethylcellulose Sodium 1%) pack... Non-Sterility Class I Kilitch Healthcare India Limited
Nov 13, 2023 EQUATE brand Hydration PF Lubricant Eye Drops (Polyethylene glycol 400 0.4% a... Non-Sterility Class I Kilitch Healthcare India Limited
Nov 13, 2023 CVS Health brand Lubricant Eye Drops (Propylene glycol 0.6%), packaged in a) ... Non-Sterility Class I Kilitch Healthcare India Limited
Nov 13, 2023 LUBRICANT EYE DROPS (Carboxymethylcellulose Sodium 0.5%), packaged 0.5 FL OZ ... Non-Sterility Class I Kilitch Healthcare India Limited
Nov 13, 2023 Leader brand Lubricant Eye Drops (Propylene glycol Eye Drops 0.6%), packaged ... Non-Sterility Class I Kilitch Healthcare India Limited
Nov 13, 2023 Leader brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Te... Non-Sterility Class I Kilitch Healthcare India Limited
Nov 13, 2023 Rugby brand Lubricating Tears Eye Drops (Dextran 70 0.1%, Hypromellose 2910 0... Non-Sterility Class I Kilitch Healthcare India Limited
Nov 13, 2023 CVS Health brand Lubricating Gel Drops (Polyethylene glycol 400 0.4% and Prop... Non-Sterility Class I Kilitch Healthcare India Limited
Nov 13, 2023 CVS brand Multi Action Relief Drops (Polyvinyl alcohol 0.5%, Povidone 0.6%, T... Non-Sterility Class I Kilitch Healthcare India Limited
Nov 13, 2023 Multi-action Relief Drops (Polyvinyl alcohol 0.5%, Providone 0.6%, Tetrahydro... Non-Sterility Class I Kilitch Healthcare India Limited
Nov 13, 2023 CVS Health brand Mild Moderate Lubricating Eye Drops (Propylene glycol 400 0.... Non-Sterility Class I Kilitch Healthcare India Limited
Nov 13, 2023 Target brand High Performance Lubricant Eye Drops (Polyethylene glycol 400 0.... Non-Sterility Class I Kilitch Healthcare India Limited
Nov 13, 2023 CVS Health brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), pa... Non-Sterility Class I Kilitch Healthcare India Limited
Nov 13, 2023 Velocity Pharma brand Lubricating Eye Drop (Propylene glycol Eye Drops 0.6%),... Non-Sterility Class I Kilitch Healthcare India Limited
Nov 13, 2023 Up&Up brand dry eye relief (Carboxymethylcellulose 0.5%) packaged in 0.5 FL O... Non-Sterility Class I Kilitch Healthcare India Limited
Nov 9, 2023 fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 m... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 fentaNYL 2,500 mcg/50 mL Injection (Concentration = 50 mcg/mL), INTRAVENOUS U... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentrat... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 SUCcinylcholine Chloride 200 mg/10mL Injection (Concentration = 20mg/mL), 10 ... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentrat... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 HYDROmorphone HCl 30 mg/30mL in 0.9% Sodium Chloride Injection, (Concentratio... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 VANCOMYCIN 1.25 g added to 0.9% Sodium Chloride 250 mL Injection, 250 mL bag,... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentratio... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.075% in 0.9% Sodium Chloride 100 m... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentr... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 m... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.